The PErineal Assessment and Repair Longitudinal Study (PEARLS): a national quality improvement initiative to improve the assessment and immediate, short and long term management of perineal trauma

ISRCTN	ISRCTN28960026
DOI	https://doi.org/10.1186/ISRCTN28960026
Protocol serial number	07/MRE12/2
Sponsor	Royal College of Midwives (UK)
Funder	Health Foundation - Quality Improvement Initiative (UK)

Submission date: 20/08/2007
Registration date: 26/03/2008
Last edited: 27/09/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Ms Sue Macdonald
Scientific

15 Mansfield Street
London
W1G 9NH
United Kingdom

Phone	+44 (0)207 312 3468
Email	Sue.Macdonald@rcm.org.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial using a matched pair cluster design. Maternity units are the unit of randomisation.
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title
Study acronym	PEARLS
Study objectives	That the provision of an evidence based training package and its delivery to practitioners will lead to better outcomes for women following perineal trauma.
Ethics approval(s)	Thames Valley Research Ethics Committee, University of Reading. Approved in February 2007.
Health condition(s) or problem(s) studied	Perineal trauma
Intervention	A paired cluster design trial investigating the intervention of an evidence based, standardised training package delivered to midwives and obstetricians, in the assessment and management of perineal trauma. Twenty-four maternity units have been recruited and matched into 12 pairs. The training intervention will initially commence in one unit in each 'pair' (Group A) with it's matched partner continuing to provide usual care (Group B). All women in participating units will receive written information antenatally, at around 36 weeks. Following birth, further information about the study will be provided, and informed consent obtained on the Labour Ward, or prior to discharge. Women who participate will receive a pack to take home including a covering letter, 10-12 day questionnaire and a Self Addressed Envelope (SAE). Following receipt of the first questionnaire, the second questionnaire will be sent with an SAE at 3 months. Main study outcomes will be assessed at three months following cascading of the intervention in Group A units. The intervention will then be cascaded among Group B units. Please use the following contact details to request a patient information sheet: Sue Tohill/ Linda Lucking PEARLS Central Office Academic Unit of Obstetrics & Gynaecology University Hospital of North Staffordshire Newcastle Road Stoke on Trent, ST4 6QG, UK Linda Lucking: Tel: +44 (0)1782 552484; Fax: +44 (0)1782 552472; Email: Linda.Lucking@uhns.nhs.uk Sue Tohill: Tel: +44 (0)7880 942330; Email: sue.tohill@rcm-pearls.org
Intervention type	Other
Primary outcome measure(s)	21/03/2013: The previous primary outcome measures were incorrect due to an error at the time of registration. The correct primary outcome measure is as follows: Experience of perineal pain on daily activity at 10-12 days post birth. Previous primary outcome measures until 21/03/2013: Women's perspectives on what they consider important in the quality and experience of their care: 1. Infection and antibiotic treatment 2. Pain 3. Healing 4. Continence
Key secondary outcome measure(s)	21/03/2013: The previous secondary outcome measures were incorrect due to an error at the time of registration. The correct secondary outcome measures are as follows: 1. 10 - 12 days post birth: 1.1. severity of perineal pain 1.2. need for suture removal 1.3. use of pain relief duirng the previous 24 hours 1.4. uptake and duration of exclusive breastfeeding 1.5. perineal wound infection 2. Three months post birth: 2.1. Edinburgh Postnatal Depression Scale (EPDS [14]) score of ≥ 13 2.2 timing of resumption of intercourse 2.3. satisfaction with the perineal repair. 2.4. duration of exclusive breastfeeding Previous secondary outcome measures until 21/03/2013: 1. Maternal physical and psychological well-being, assessed by the 10 day and 3 month questionnaires: 1.1. Incidence of perineal pain 1.2. Use of postpartum analgesia 1.3. Perineal wound infection 1.4. Uptake and duration of breastfeeding 2. Proportion of women who have an Edinburgh Postnatal Depression Scale (EPDS) score of greater than or equal to 13 at 3 months.
Completion date	01/02/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	1000
Key inclusion criteria	All women who sustain a second degree perineal tear or episiotomy in a participating unit during the study period will be eligible. To avoid problems with selection biases, overall outcomes for the centre will be ascertained using audit data from birth records. All births during a prespecified period will contribute to these analyses.
Key exclusion criteria	1. Women under 16 years of age 2. Non-English speakers 3. Those who have suffered pregnancy loss
Date of first enrolment	01/12/2005
Date of final enrolment	01/02/2009

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

15 Mansfield Street

London
W1G 9NH
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	23/09/2013		Yes	No
Protocol article	protocol	25/02/2010		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes